MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

Zhejiang University

Status: Unknown

Conditions: Therapeutic Mechanism of Antidepressants for Refractory FD

Treatments: Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants; Other: conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03973567

2016-042

Details and patient eligibility

About

In this study, diffusion tensor imaging（DTI）technique was used to evaluate the brain microstructures and connective white matter microstructures in patients with refractory FD, resting fMRI was used to evaluate the functional connectivity between hemispheres, and neuroimaging changes after antidepressant intervention were observed to explore the activation patterns of resting brain homeostasis-receptive network areas in patients with refractory FD. We aimed to explore microstructure of white matter and gray matter and functional connectivity between hemispheres to explain the therapeutic mechanism of antidepressants.

Full description

In this study, functional magnetic resonance imaging (fMRI) was used to investigate the abnormal activation patterns of brain regions in patients with refractory FD in resting state, and to observe the changes of brain functions after antidepressant treatment, in order to find scientific evidence for exploring the etiology, neuropathological mechanism and the mechanism of antidepressant treatment of refractory FD.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-60 years old, meeting the criteria for inclusion of refractory FD
• HP infection negative
• Right handedness

Exclusion criteria

• Antidepressant drug allergists
• History of gastroduodenal surgery;
• Researchers judged suicidal ideation.
• Women in pregnancy or lactation.
• Patients with uncorrected narrow angle glaucoma.
• There was a history of epileptic seizures.
• suffering from any serious or unstable medical disease or disease.
• Addiction to illicit drugs or alcohol and unwillingness to discontinue use during the study period.
• Patients can't express their complaints correctly and can't cooperate with the researcher.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

refractory FD patients using antidepressants

Experimental group

Description:

Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, proton pump inhibitors (PPI), motivation and anti-Helicobacter pylori（HP） treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.

Treatment:

Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants

refractory FD patienTS using conventional treatment

Placebo Comparator group

Description:

Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, PPI, motivation and anti-HP treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.

Treatment:

Other: conventional therapy

normal control

No Intervention group

Description:

Age, sex and education matched, right-handed 30 normal people.